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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION
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BOSTON SCIENTIFIC CORPORATION Back to Search Results
Model Number UNK-D-PELVIC HEALTH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 08/14/2021
Event Type  Injury  
Event Description
It was reported that the patient continued to experience pain and bleeding four days after malleable penile prosthesis implant.The patient stated that the whole area was too painful to touch and they wanted to know what can be done about their penis being in permanent erection as concealing the device seems too painful.It was also mentioned that years ago they underwent a laser prostatectomy in which the cavernous nerve was damaged.Additionally, when the doctor removed the bandage from the scrotum, some of the surgical glue that was supposed to hold the incision closed came off with the bandage.The patient does not believe it is a device issue, but a healing issue and will follow up with their doctor.No further information was provided.
 
Event Description
It was reported that the patient continued to experience pain and bleeding four days after malleable penile prosthesis implant.The patient stated that the whole area was too painful to touch and they wanted to know what can be done about their penis being in permanent erection as concealing the device seems too painful.It was also mentioned that years ago they underwent a laser prostatectomy in which the cavernous nerve was damaged.Additionally, when the doctor removed the bandage from the scrotum, some of the surgical glue that was supposed to hold the incision closed came off with the bandage.The patient does not believe it is a device issue, but a healing issue and will follow up with their doctor.No further information was provided.
 
Manufacturer Narrative
Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the ams spp instructions for use (ifu).The spp ifu lists pain and bleeding as a potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
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Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12435757
MDR Text Key270258171
Report Number2124215-2021-26840
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNK-D-PELVIC HEALTH
Device Catalogue NumberUNK-D-PELVIC HEALTH
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/14/2021
Initial Date FDA Received09/07/2021
Supplement Dates Manufacturer Received09/14/2021
Supplement Dates FDA Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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